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Panel C: MK-8189 Dosing Regimen 3 for Bipolar Disorder

Phase 1

Recruiting

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of receiving and tolerating antipsychotic medication within the usual dose range employed for bipolar I disorder

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to ~28 days

Awards & highlights

Study Summary

This trial aims to assess how safe and well-tolerated MK-8189 is in individuals with stable bipolar I disorder. The study will not involve testing specific hypotheses.

Who is the study for?

This trial is for adults with a stable form of bipolar I disorder, who have previously tolerated antipsychotic medication. Participants must have a body mass index between 18 and 40 kg/m^2 and can discontinue current antipsychotics at least 5 days before the study starts.Check my eligibility

What is being tested?

The study is testing MK-8189, a potential treatment for bipolar I disorder. It will compare the effects of MK-8189 against a placebo (a substance with no active drug) to assess its safety and tolerability in participants.See study design

What are the potential side effects?

Since this trial aims to evaluate safety, specific side effects are not listed but may include typical reactions to psychiatric medications such as drowsiness, weight changes, dry mouth, restlessness or digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have taken and tolerated antipsychotic medication for bipolar I disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Who Discontinue Study Treatment Due to an AE

Number of Participants Who Experience One or More Adverse Events (AEs)

Side effects data

From 2018 Phase 2 trial • 224 Patients • NCT03055338

18%

Akathisia

16%

Nausea

16%

Headache

Dystonia

Diarrhoea

Vomiting

Sedation

Anxiety

Decreased appetite

Somnolence

Insomnia

Dyspepsia

Dizziness

Weight increased

Fatigue

Agitation

Lethargy

100%

80%

60%

40%

20%

Study treatment Arm

MK-8189

Risperidone

Placebo

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Panel C: MK-8189 Dosing Regimen 3Experimental Treatment1 Intervention

Participants will receive MK-8189 QD at dosing regimen 3 for up to 14 days.

Group II: Panel B: MK-8189 Dosing Regimen 2Experimental Treatment1 Intervention

Participants will receive MK-8189 QD at dosing regimen 2 for up to 14 days.

Group III: Panel A: MK-8189 Dosing Regimen 1Experimental Treatment1 Intervention

Participants will receive MK-8189 once daily (QD) at dosing regimen 1 for up to 14 days.

Group IV: PlaceboPlacebo Group1 Intervention

Participants will receive MK-8189-matching placebo QD for up to 14 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-8189

2020

Completed Phase 2

~640

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,896 Previous Clinical Trials

5,062,686 Total Patients Enrolled

4 Trials studying Bipolar Disorder

1,312 Patients Enrolled for Bipolar Disorder

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,782 Previous Clinical Trials

8,066,284 Total Patients Enrolled

9 Trials studying Bipolar Disorder

2,098 Patients Enrolled for Bipolar Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals older than 25 years being sought out for participation in this medical study?

"Individuals aged above 18 years and below 60 years are eligible for recruitment into this research study."

Answered by AI

How many individuals are currently enrolled as participants in this clinical trial?

"Indeed, clinicaltrials.gov data confirms that this trial is actively seeking participants. Originally posted on April 8th, 2024, it was last updated on April 22nd, 2024. The study aims to recruit 32 patients from a single site."

Answered by AI

Are researchers actively seeking participants for this ongoing clinical trial?

"As per clinicaltrials.gov, the current status of this trial involves enrolling new participants. The initial posting date for this study was 4/8/2024 with the most recent update made on 4/22/2024."

Answered by AI

Has the dosing schedule labeled as Panel C for MK-8189 been granted approval by the Food and Drug Administration (FDA)?

"The safety rating for Panel C: MK-8189 Dosing Regimen 3 is marked as a 1 by our team at Power. This score reflects the early Phase 1 nature of the trial, indicating that there is minimal data available to support both safety and efficacy at this stage."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of MK-8189 in Participants With Bipolar I Disorder (MK-8189-020)

2024. "A Study of MK-8189 in Participants With Bipolar I Disorder (MK-8189-020)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06273774.

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